This document clarifies the responsibilities of those involved in clinical trials to monitor and report adverse events and other safety issues. Supplementary guidance on other clinical trial safety monitoring and reporting issues is also available*.
This Guidance specifically addresses the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials involving investigational medicinal products and investigational medical devices for trials conducted under the Clinical Trial Approval (CTA) or Clinical Trial Notification (CTN) schemes. The Guidance is also broadly applicable to all clinical trials involving therapeutic goods.
NHMRC has also developed the following documents to supplement the Guidance and to provide further advice for non-commercial and commercially-sponsored clinical trials involving therapeutic goods. This supplementary guidance covers the following topics:
- Data Safety Monitoring Boards (DSMBs)
- Risk-based Management and Monitoring of Clinical Trials involving Therapeutic Goods
- Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods.
Until 30 June 2018, the supplementary guidance on Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods should be read alongside the Australian Code for the Responsible Conduct of Research (2007).
From 1 July 2019, the supplementary guidance on Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials involving Therapeutic Goods should be read alongside the Australian Code for the responsible Conduct of Research (2018) (the Code) and the Guide to Managing and Investigating Potential Breaches of the Code (2018) (PDF 530 KB)
* The name of the 'Clinical Trial Exemption (CTX) scheme' changed to the 'Clinical Trial Approval (CTA) scheme' in 2020. This change was instigated to more accurately reflect the nature of the scheme under the Therapeutic Goods Act 1989. References in linked documents to CTX should now be interpreted as references to CTA.